Food and Drug Administration

                                                                                                                                Rockville MD 20857

 

STAMPED MAR 25, 199(?)

NDA 18-644

 

Burroughs-Wellcome Company

Attention: Michael J. Dalton, Pharm.D.

Head, Department of Pharmaceutical Products

Drug Regulatory Affairs

3030 Cornwallis Road

Research Triangle Park, North Carolina 27709

 

Dear Dr. Dalton:

Please refer to (unreadable) New Drug Application submitted pursuant to section 505(b) of the Federal Food, Drug, and Cosmetic Act for Wellbutrin^R (bupropion hydrochloride) tablets.

 

We acknowledge receipt of your amendment dated November 20, 1990, requested our opinion whether your proposal would support a labeling change to permit bid dosing of Wellbutrin^R at 300 mg/day.

 

Reference is also made to telephone conversations on November 14 and 28, 1990, between Dr. Loren Miller of your firm and Dr. Thomas Laughren of this Agency, regarding what data would be required to gain approval of a sustained release formulation of Wellbutrin^R.

 

We have completed our review of your requests and have the following recommendations:

 

We agree that a clinical study demonstrating the safety and effectiveness of the 50 mg bid dosing would not be necessary.  However, given the limited data available about the steady-state pharmacokinetics of bupropion, and particularly the morpholinol metabolite, we are not prepared to rely on simulations alone.  Therefore, we would want to see data from actual studies comparing the pharmacokinetics of bupropion and the morpholinol metabolite in 100 mg tid and 150 mg bid dosing.

 

Regarding your more informal request for advice about what studies might be needed to support a sustained release form of Wellbutrin^R, we again feel that it would not be necessary to demonstrate the safety and effectiveness of such a product in a clinical trial.  However, you would, at a minimum, need to demonstrate that such a product, when given at a total dose of 300 mg/day, resulted in a steady-state plasma levels of bupropion and the morpholinol metabolite that fell within the time-concentration windows for these entities seen with 100 mg tid dosing with the immediate release form.

 

 

 

 

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